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Empagliflozin vs Metformin in PCOS

NCT03008551 on ClinicalTrials.gov Phase 2/3 Hull University Teaching Hospitals NHS Trust (government) Started 2017-08-18 Completed
Riskier than 16% of active trials
this trial: 10% 0% 36%

Model scores of the 29,894 trials active now.

Model score 10% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 7% of the time (56 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2018-04-02, after 2017-08-18 start.

The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.

Termination over time, as the model saw it at the start

0% 22% 45% 67% 89% 0123456 yr completed 78% terminated 14%

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2018-04-02. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

What moved the score

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

The trial

Design

Phase
2/3 (typical: 2)
Number of arms
2
Allocation
randomized
Design
parallel
Primary purpose
health services research (typical: treatment)
Blinding
none
Has a data monitoring committee
Yes (typical: 56% yes)
Responsible party
sponsor
Collaborators
0
Keywords listed
0 (typical: 1)

Who can join

Minimum age
18
Maximum age
45 (typical: 71)
Sex
female (typical: all)
Accepts healthy volunteers
No (typical: 9% yes)

Sponsor's track record

Sponsor type
government (typical: academic or other)
Sponsor's past trials
35 (typical: 32)
Sponsor's past termination rate
2.9% (typical: 9.9%)
Trials the sponsor started in the prior 2 years
12 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history
2 (typical: 1)
Drug has FAERS history
Yes (typical: 64% yes)
Drug's FAERS reports before start
198940 (typical: 2148)
Drug's FAERS reports in the prior 12 months
35427 (typical: 412.5)
Drug's FAERS reports marked serious
62.4% (typical: 85.6%)
Drug's FAERS reports with a death
7.6% (typical: 15.9%)

Disease area and drugs

Disease areas
cancer, urogenital, endocrine
Drugs matched to FDA substances
empagliflozin, metformin

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

Similar finished trials

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.